AccessGUDID - DEVICE: NA (04719872780014)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: PG-IC01A-024
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PHARMIGENE, Inc.

Primary DI Number: 04719872780014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658637223 *Terms of Use

Device Description: The PGIC01 Detection Reagent is used for amplification of an internal control gene.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61280	Killer cell immunoglobulin-like receptor (KIR) genotype/HLA ligand detection IVD, primer	A defined piece of single-stranded nucleic acid which binds to and initiates replication of a target nucleic acid template in an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple polymorphisms associated with killer cell immunoglobulin-like receptors (KIR) and/or their HLA associated ligands. KIR genotypes detected may include but are not limited to KIR2DL4, KIR3DL2, and KIR3DP1, associated with immune responses e.g., graft versus host disease, autoimmune disease and acute organ rejection.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVU	Reagents, Specific, Analyte

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -25 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 823084fe-9bfb-4adb-a01b-10651d577db2
Public Version Date: June 22, 2023
Public Version Number: 1
DI Record Publish Date: June 14, 2023